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Risk factors for CAR-T cell manufacturing failure among DLBCL patients: A nationwide survey in Japan
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- Jo, Tomoyasu
- Department of Clinical Laboratory Medicine and Center for Research and Application of Cellular Therapy, Kyoto University Hospital; Department of Hematology and Oncology, Kyoto University Hospital
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- Yoshihara, Satoshi
- Department of Transfusion Medicine and Cell Therapy, Hyogo Medical University Hospital; Department of Hematology, Hyogo Medical University Hospital
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- Okuyama, Yoshiki
- Division of Transfusion and Cell Therapy, Tokyo Metropolitan Komagome Hospital
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- Fujii, Keiko
- Division of Transfusion, Okayama University Hospital
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- Henzan, Tomoko
- Center for Cellular and Molecular Medicine, Kyushu University Hospital
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- Kahata, Kaoru
- Department of Hematology, Hokkaido University, Faculty of Medicine
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- Yamazaki, Rie
- Center for Transfusion Medicine and Cell Therapy, Keio University School of Medicine
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- Takeda, Wataru
- Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital
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- Umezawa, Yoshihiro
- Department of Hematology, Tokyo Medical and Dental University
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- Fukushima, Kentaro
- Department of Hematology and Oncology, Osaka University Graduate School of Medicine
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- Ashida, Takashi
- Division of Hematology and Rheumatology, Department of Internal Medicine, Kindai University Hospital
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- Yamada‐Fujiwara, Minami
- Division of Blood Transfusion and Cell Therapy, Tohoku University Hospital
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- Hanajiri, Ryo
- Department of Hematology and Oncology, Nagoya University Graduate School of Medicine
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- Yonetani, Noboru
- Department of Hematology, Kobe City Medical Center General Hospital
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- Tada, Yuma
- Department of Hematology, Osaka International Cancer Institute
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- Shimura, Yuji
- Department of Blood Transfusion, University Hospital, Kyoto Prefectural University of Medicine
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- Nishikii, Hidekazu
- Department of Hematology, University of Tsukuba
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- Shiba, Norio
- Department of Division of Blood Transfusion and Cell Therapy, Yokohama City University
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- Mimura, Naoya
- Department of Transfusion Medicine and Cell Therapy, Chiba University Hospital
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- Ando, Jun
- Department of Cell Therapy and Transfusion Medicine, Juntendo University School of Medicine
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- Sato, Takayuki
- Department of Haematology and Oncology, Kurashiki Central Hospital
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- Nakashima, Yasuhiro
- Department of Hematology, Osaka Metropolitan University Hospital
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- Ikemoto, Junko
- Department of Hematology, Hyogo Medical University Hospital
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- Iwaki, Keita
- Division of Blood Transfusion and Cell Therapy, Tohoku University Hospital
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- Fujiwara, Shin‐ichiro
- Division of Cell Transplantation and Transfusion, Jichi Medical University Hospital
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- Ri, Masaki
- Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences
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- Nagamura‐Inoue, Tokiko
- Department of Cell Processing and Transfusion, The Institute of Medical Science, The University of Tokyo
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- Tanosaki, Ryuji
- Department of Hematology, Hokkaido University, Faculty of Medicine
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- Arai, Yasuyuki
- Department of Clinical Laboratory Medicine and Center for Research and Application of Cellular Therapy, Kyoto University Hospital; Department of Hematology and Oncology, Kyoto University Hospital
Bibliographic Information
- Other Title
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- Risk factors for <scp>CAR‐T</scp> cell manufacturing failure among <scp>DLBCL</scp> patients: A nationwide survey in Japan
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Description
For successful chimeric antigen receptor T (CAR-T) cell therapy, CAR-T cells must be manufactured without failure caused by suboptimal expansion. In order to determine risk factors for CAR-T cell manufacturing failure, we performed a nationwide cohort study in Japan and analysed patients with diffuse large B-cell lymphoma (DLBCL) who underwent tisagenlecleucel production. We compared clinical factors between 30 cases that failed (7.4%) with those that succeeded (n = 378). Among the failures, the proportion of patients previously treated with bendamustine (43.3% vs. 14.8%; p < 0.001) was significantly higher, and their platelet counts (12.0 vs. 17.0 × 10⁴/μL; p = 0.01) and CD4/CD8 T-cell ratio (0.30 vs. 0.56; p < 0.01) in peripheral blood at apheresis were significantly lower than in the successful group. Multivariate analysis revealed that repeated bendamustine use with short washout periods prior to apheresis (odds ratio [OR], 5.52; p = 0.013 for ≥6 cycles with washout period of 3–24 months; OR, 57.09; p = 0.005 for ≥3 cycles with washout period of <3 months), low platelet counts (OR, 0.495 per 105/μL; p = 0.022) or low CD4/CD8 ratios (<one third) (OR, 3.249; p = 0.011) in peripheral blood at apheresis increased the risk of manufacturing failure. Manufacturing failure remains an obstacle to CAR-T cell therapy for DLBCL patients. Avoiding risk factors, such as repeated bendamustine administration without sufficient washout, and risk-adapted strategies may help to optimize CAR-T cell therapy for DLBCL patients.
Journal
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- British Journal of Haematology
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British Journal of Haematology 202 (2), 256-266, 2023-07
British Society for Haematology
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Details 詳細情報について
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- CRID
- 1050015333084131840
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- ISSN
- 13652141
- 00071048
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- HANDLE
- 2433/284127
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- PubMed
- 37096915
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- Text Lang
- en
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- Article Type
- journal article
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- Data Source
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- IRDB
- Crossref
- KAKEN
- OpenAIRE